C-Reactive Protein and Sodium in Predicting Anastomotic Leakage

Anastomotic leakage is serious morbidity that can develop in patients operated on for colorectal cancer and can reach potentially life-threatening dimensions. Many international studies have been conducted to reduce and eliminate this postoperative complication that may have a mortal course. In these studies, preoperative, perioperative and postoperative factors of the patient, operation techniques, structure of the material used in the operation and multiple factors belonging to the surgeon were held responsible. Intraabdominal sepsis secondary to late anastomotic leakage and subsequent multiorgan failure can cost the patient's life. Anastomotic leaks that develop in patients who have been operated for colorectal cancer; In order to detect patients' postoperative clinical findings, laboratory examinations, imaging tests, and to eliminate them before intraabdominal sepsis develops, studies including many different laboratory and imaging methods have been carried out. Although previous studies have shown that there are many laboratory examinations and imaging methods that can predict anastomotic leaks early, they have many advantages over each other in terms of efficiency, sensitivity, specificity, and cost.

The investigators aimed to investigate the effectiveness of C reactive protein and blood sodium value, as well as their superiority, among the tests that can predict postoperative anastomotic leakage, especially in patients who have undergone a single anastomosis following resection for non-metastatic colorectal cancer.

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Key information

Conditions

Colorectal Cancer Anastomotic Leak Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hyponatremia Intestinal Diseases Intestinal Neoplasms Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tepecik Training and Research Hospital

Izmir, 35180, Turkey (Türkiye)

About this study

Investigate the effectiveness of postoperative C-reactive protein and sodium values in predicting anastomotic leakage in the early postoperative period in patients who have undergone anastomosis following resection for non-metastatic colorectal cancer, and their superiority to each other.
Investigate the effectiveness of these laboratory parameters in developing anastomotic leaks according to tumor location and different age subgroups (<45 years, 45-65 years,> 65 years).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients over the age of 18 who were operated due to elective colorectal cancer
Patients who are known to have no solid organ metastases in preoperative imaging methods and whose perioperative surgery notes support this finding
Patients with ileocolic, colocolic, colorectal anastomosis during the operation
Patients whose postoperative 1,3,5th day C- Reactive protein and sodium values were measured

Exclusion criteria

Patients under the age of 18
Emergency operated patients
Patients on a routine dialysis program due to Chronic renal failure
Patients with a known diagnosis of liver cirrhosis
Patients who are irresectable during the operation and therefore have undergone palliative surgery
Patients whose C- Reactive protein and Sodium values were not measured on the postoperative 1, 3, 5th day
Patients with abdominoperineal resection and no bowel anastomosis during the operation
Patients who have not undergone ileocolic, colocolic, colorectal or ileorectal anastomosis during the operation.
Patients found to be metastatic during the operation
Patients who have undergone additional surgical resection (metastasectomy, etc.) due to solid organ metastasis during the operation
Patients who have had more than one gastrointestinal anastomosis during the same surgery
Patients undergoing concurrent hyperthermic intraperitoneal chemotherapy (HIPEC) and / or cytoreductive surgery

Treatment and study plan

Biochemical test

Diagnostic Test

C Reactive protein and sodium

Primary outcomes

Early predictive factors of anastomotic leakege

Time frame: 2 or 3 days

The anastomotic leak of the measurement The measurement tool is the laboratory parameters.

Sponsors and collaborators

Lead sponsor

Tepecik Training and Research Hospital

Other

Registry information

Official study title

The Effect of Postoperative C-Reactive Protein and Sodium Value on the Early Prediction of Anastomotic Leaks in Patients Operated on for Colorectal Cancer

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2019
First posted: Jan 22, 2021
Registry last updated: Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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